Requisition ID: 1805695831W
Overall purpose of
This role aims to support key
compliance requirements for GQP ordinance in Japan and J&J global
standards for Business Quality (BQ). The role will help ensure there is
appropriate Marketing Authorization Holder (MAH) oversight of all supplying
manufacturers to Japan local operating company.
Essential duties and
Responsibilities include, but not
- Review consistency of the manufacturing, specifications,
product release criteria and test methods with the registered dossiers in
Japan at all times.
- Review any manufacturing changes and deviations impact to
MAH, Japanese customer requirements and compliance status to registered dossiers
- Report (escalate) any issues to the Quality Assurance
- Collaborate effectively with various internal and
external partners, such as the local Health Authorities, the LSO, the
manufacturing plant QA, the logistic department and any other functions
supporting complaint investigations.
- Review corrective and preventive actions related any
and monitor (where applicable) the temperature conditions during transportation,
storage and distribution for all temperature sensitive products.
- Support conduct
of regular (self-) inspections that are applicable on the supply chain network
within the responsibilities of the MAH.
- Initiates and tracks Quality Agreement with Manufacturers,
Contract Laboratories and Logistic Service Providers as needed.
- Contribute to the BQ mission, vision and strategy
- Contribute to Quality deliverables for Japan product
- Support GxP system (CAPA, Change Control, Deviation,
Quality issue, Training etc.)
- Contribute the GMP Intelligence Program to assess and
monitor Japanese regulations, standards and guidance documents related to
GxP, product testing and Japanese Pharmacopoeia requirements.
l +2 years
of directly related experience in quality assurance and quality related
with basic knowledge in manufacturing process, problem solving/investigation
tools, product quality and GxP audits
ability to manage relationship, development and maintenance, and negotiation
Other features of the
J&J Tokyo Head Office, Japan
with Japanese pharmaceutical companies
- Good communication
skills both in English and Japanese
- Good verbal
and written communications skills. Must be able to effectively articulate
ideas with different levels in the organization.
in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
required for this role:
- Leadership as an
individual contributor to challenge the status quo and how things have
always been done.
with high personal integrity and application of J&J
Values in daily operations.
experience leading projects, programs or other
show his/her agility, ability to learn fast and comfort in complex
- Must have
demonstrated interpersonal skills, including temperament, objectivity and
approach that will facilitate effective interactions with key
Janssen Pharmaceutical K.K. (7195)ジョブ
Quality AssuranceRequisition ID